Gupte Poonam Ashish, Giramkar Shital Ashok, Harke Shubhangi Mandar, Kulkarni Sneha Keshav, Deshmukh Amol Panjabrao, Hingorani Lal Lachhmandas, Mahajan Madhavi Prabhakar, Bhalerao Supriya Sudhakar
Obesity Diabetes lab, Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth Deemed University Campus, Pune, Maharashtra, India.
Research and Development Department, Pharmanza Herbals Pvt. Ltd., Dharmaj, Gujrat, India.
J Inflamm Res. 2019 Jun 5;12:145-152. doi: 10.2147/JIR.S205390. eCollection 2019.
Osteoarthritis is the single most common cause of disability in older adults with an estimated 10% to 15% prevalence in individuals above 60 years. The contemporary medications include nonsteroidal anti-inflammatory drugs acetaminophen, cyclooxygenase-2 inhibitors, and surgical interventions. In view of safety issues regarding their longterm use, necessitating search for effective and safe alternatives, we evaluated Capsule Longvida Optimized Curcumin prepared using solid lipid curcumin particles (SLCP) technology in patients with knee osteoarthritis. Eligible patients fulfilling American College of Rheumatology Criteria were randomized to SLCP group (400 mg twice daily delivering 80 mg of curcumin per capsule) or Ibuprofen with placebo group (400 mg each once daily) for 90 days. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Visual Analog Scale (VAS) were used for clinical assessment of knee pain and function. Degree of knee flexion and swelling were also noted. Blood biochemistry included hemogram, blood urea, creatinine, Random blood sugar and inflammatory markers viz. PGE2, TNF α, IL6, IL1β and LTB4 while urine examination included degenerative marker CTX II. The parametric data was analyzed using unpaired test while non-parametric data was analyzed using Friedman's test or Mann Whitney test as applicable. A level of <0.05 was considered as statistically significant. Out of 50 recruitments, 25 from the Ibuprofen group and 17 from the SLCP group completed the study with significant improvements in VAS and WOMAC scores indicating comparable efficacy of SLCP in alleviating pain with Ibuprofen. None of the markers displayed significant changes. Except one withdrawal in the study group due to rash and itching, the study drug was found safe. SLCP in a dose of 160 mg daily was found to be effective and safe in alleviating symptoms in patients suffering from knee osteoarthritis when administered for 90 days.
骨关节炎是老年人残疾的最常见单一原因，估计60岁以上人群的患病率为10%至15%。当代药物包括非甾体抗炎药、对乙酰氨基酚、环氧化酶-2抑制剂和手术干预措施。鉴于其长期使用的安全性问题，需要寻找有效且安全的替代方案，我们对采用固体脂质姜黄素颗粒（SLCP）技术制备的Longvida优化姜黄素胶囊在膝骨关节炎患者中进行了评估。符合美国风湿病学会标准的合格患者被随机分为SLCP组（每日两次，每次400毫克，每粒胶囊含80毫克姜黄素）或布洛芬加安慰剂组（各400毫克，每日一次），为期90天。采用西安大略和麦克马斯特大学骨关节炎指数（WOMAC）和视觉模拟量表（VAS）对膝关节疼痛和功能进行临床评估。还记录了膝关节屈曲和肿胀程度。血液生化指标包括血常规、血尿素、肌酐、随机血糖和炎症标志物，即前列腺素E2、肿瘤坏死因子α、白细胞介素6、白细胞介素1β和白三烯B4，而尿液检查包括退变标志物CTX II。参数数据采用不成对t检验分析，非参数数据根据适用情况采用弗里德曼检验或曼-惠特尼检验分析。P<0.05被认为具有统计学意义。在50名招募的患者中，布洛芬组的25名和SLCP组的17名完成了研究，VAS和WOMAC评分有显著改善，表明SLCP在缓解疼痛方面与布洛芬具有相当的疗效。所有标志物均未显示出显著变化。除研究组有1例因皮疹和瘙痒退出外，研究药物被认为是安全的。发现每日剂量为160毫克的SLCP在给药90天时对缓解膝骨关节炎患者的症状有效且安全。
